Healthy Skepticism Library item: 7047

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Publication type: Journal Article

Lenzer J.
Researcher received undisclosed payments of 300,000 dollars from Pfizer.
BMJ 2006 Dec 16; 333:(7581):1237

Abstract:

A federal research scientist working for the US National Institute of Mental Health (NIMH) pleaded guilty last week to a charge that he had not declared a conflict of interest to his employers.

Pearson “Trey” Sunderland III, pleaded guilty to a misdemeanour charge that he failed to report about $300 000 (£150 000; 230 000) worth of consulting fees and expense payments from Pfizer. Under the plea agreement, Dr Sunderland will pay back the $300 000 to the federal government, and prosecutors say they plan to recommend that he also serve 400 hours of community service and be placed on probation for two years.

Dr Sunderland’s activities came under scrutiny when Susan Molchan, a former NIMH researcher, blew the whistle on him when she suspected that he had diverted samples of cerebrospinal fluid that she had obtained during a study of 25 subjects.

When Dr Molchan left the NIMH in 1997, the samples came under the control of Dr Sunderland. Dr Molchan became suspicious when in 2004 she tried to obtain some of the samples, but Dr Sunderland was only able to account for 2-3% of the cerebrospinal fluid that should still have been in storage. When Dr Molchan asked for the linked clinical data, Dr Sunderland told her that it had been purged because it was more than 5-7 years old.

Dr Molchan’s charges triggered a Congressional inquiry. A report issued by the House Committee on Energy and Commerce in June concluded that Sunderland had transferred more than 3200 samples of cerebrospinal fluid and plasma to Pfizer.

According to the report, cerebrospinal fluid samples from 538 subjects, who participated in 14 studies at NIMH, were sent to Pfizer, including subjects from Dr Molchan’s study. The committee found that there were “reasonable grounds” to conclude that Dr Sunderland received compensation from Pfizer “for activities that were derived directly from his official acts in providing Pfizer access to spinal fluid samples … and linked clinical data and that Dr Sunderland used NIH employees and resources to provide such access.”

The samples were considered “extraordinarily valuable” because they were obtained at several points over a period of years. The samples were prized for their ability to aid in the identification of biomarkers in early Alzheimer’s disease.

In a 2003 article in JAMA, Dr Sunderland analysed the early identification of biomarkers (2003;289:2094-103) but did not expose his financial ties to Pfizer.

Dr Sunderland also endorsed cholinesterase inhibitors, including donepezil (Aricept, Pfizer), as a treatment for Alzheimer’s disease in medical journal articles. For example, in the Journal of Clinical Psychiatry he wrote, “Donepezil, recently approved for use in mild to moderate Alzheimer’s disease, appears to be less toxic and better tolerated than tacrine,” again without explaining his financial ties to Pfizer (1998;59(suppl):s31-5).

The report also found that separate from his undeclared consulting fees with Pfizer, he received $311 150 in lecture fees between 1996 and 2004, for talks that were, the committee observed, “arranged by Pfizer’s marketing team charged with promoting Aricept.”

Donepezil is the top selling drug for Alzheimer’s disease, with $1.67bn in 2005-6 in sales last year.

The report raised questions about the nature of informed consent from the human subjects who donated their tissue samples because most subjects, according to the report, were not told about the Pfizer “collaboration.”

Vera Sharav, president of the Alliance for Human Research Protection, said, “This is theft. Researchers are helping themselves to a gold mine of body tissues.”

The committee found that the NIH “had no uniform, centralized and mandatory authority regulating the handling of human tissue samples.” An NIH spokesperson, John Burklow, told the Washington Post in June that the agency is “evaluating the process of material transfer out of NIH and will be clarifying current rules” (Washington Post 2006, 14 Jun).

The NIH did not respond to inquiries at this time.